Metformin Hydrochloride
- Product NDC
- 51655-368
- 11-digit product format
- 516550368
- Labeler code
- 51655
- Product ID
- 51655-368_48ebae7a-12c6-3ef3-e063-6294a90a0f21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2020-06-04
- Marketing end
- 2026-11-30
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860981 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-368-52 | Metformin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-368 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230420_ab80521b-5014-cc2a-e053-2a95a90a2003.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51655-368-52 | 51655036852 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-368-52) | 2020-06-04 | 2026-11-30 | No | No | Current |